Press Release : ObsEva SA presents posters at the ACOG Annual Clinical and Scientific Virtual Meeting April 30 - May 2, 2021

 
   GENEVA, Switzerland and BOSTON, MA -- April 30, 2021 -- ObsEva SA 
(NASDAQ: OBSV / SIX: OBSN) a biopharmaceutical company developing and 
commercializing novel therapies to improve women's reproductive health, 
today announced the presentation of five e-Posters on linzagolix in the 
treatment of uterine fibroids at the American College of Obstetricians 
and Gynecologists (ACOG) Annual Clinical and Scientific Meeting (ACSM), 
which will take place virtually from April 30 to May 2, 2021. 
 
   The data presented further substantiate the best-in-class potential of 
linzagolix for the treatment of heavy menstrual bleeding (HMB) due to 
uterine fibroids addressing both key efficacy and safety parameters from 
the PRIMROSE Phase 3 program. 
 
   The posters being presented, along with lead authors and key conclusions 
are: 
 
 
 
   Poster #196: 
 
   Effects of the oral GnRH antagonist linzagolix on uterine and fibroid 
volume in two Phase 3 trials 
 
   Lead author: Jacques Donnez, MD, PhD; Professor, Société de 
Recherche pour l'Infertilité (SRI), Brussels and Catholic 
University of Louvain, Belgium 
 
   Key Conclusions: The 200 mg dose of linzagolix without hormonal add-back 
therapy (ABT) was the only dose to show consistent substantial and 
significant reductions in uterine and fibroid volumes. Linzagolix is the 
only GnRH antagonist with a high-dose non-ABT option with the potential 
for short-term use for reduction of uterine and fibroid volume. 
 
   Poster #231: 
 
   Impact of linzagolix on pain in patients with fibroid-related heavy 
menstrual bleeding: results of two Phase 3 trials 
 
   Lead author: Ayman Al-Hendy, MD, PhD; Professor, Department of 
Obstetrics and Gynecology, University of Chicago 
 
   Key Conclusions: Linzagolix 100 and 200 mg, with and without ABT, 
consistently improved pain in women with fibroid-associated HMB.  Pain 
reduction in the treatment groups was achieved after 12 weeks and was 
maintained up to 52 weeks.  By 12 weeks following termination of 
treatment, pain scores had increased but had not reached baseline 
levels. 
 
   Poster #2962: 
 
   Impact of linzagolix treatment on anemia in women with uterine fibroid 
related heavy menstrual bleeding:  results of two Phase 3 clinical 
trials 
 
   Lead author: William Catherino, MD, PhD; Professor, Department of 
Gynecologic Surgery and Obstetrics, Uniformed Services University of the 
Health Sciences 
 
   Key Conclusions: High and low linzagolix doses with and without ABT 
improved hemoglobin and ferritin levels in anemic women with uterine 
fibroids. In the 12-week follow-up period hemoglobin levels decreased 
but did not return to baseline levels. 
 
   Poster #194: 
 
   Safety of linzagolix in the treatment of women with uterine fibroids: 
Results from two Phase 3 clinical trials 
 
   Lead author: Hugh Taylor, MD; Professor, Department of Obstetrics, 
Gynecology and Reproductive Sciences, Yale School of Medicine 
 
   Key Conclusions: Overall treatment emergent adverse event (TEAE) rates 
at 24 weeks were similar to placebo for the linzagolix 100 mg and 200 mg 
with ABT regimens. Lumbar spine bone mineral density (BMD) z-scores 
indicated no change in risk categories. TEAE rates at Week 24 and BMD up 
to 52 weeks support the potential for long term use of linzagolix 100 mg 
and 200 mg with ABT. 
 
   Poster #1868: 
 
   Impact of linzagolix on events of depression and other mood disorders in 
women with uterine fibroids 
 
   Lead author: Robert Taylor, MD, PhD; Professor, Obstetrics and 
Gynecology, University at Buffalo 
 
   Key Conclusions: In the Phase 3 uterine fibroids trials of linzagolix, 
the incidence of depression and other mood disorder adverse events was 
low and revealed no consistent drug-related pattern. 
 
   All ePosters will be displayed on the ACOG Annual Meeting virtual 
platform in gallery view with search features by title, topic, and 
category. Each ePoster will have a dedicated page that will include a 
5-minute prerecorded ePoster preview. 
 
 
 
   About Uterine Fibroids 
 
   Uterine fibroids are common benign tumors of the muscular tissue of the 
uterus. Uterine fibroids affect women of childbearing age and can vary 
in size from undetectable to large bulky masses. Few long-term medical 
treatments are available, and as a result, approximately 300,000 
hysterectomies are performed for uterine fibroids every year in the US. 
The symptoms of uterine fibroids are wide-ranging and include heavy 
menstrual bleeding, anemia, pelvic pressure and bloating, urinary 
frequency and pain that can be extremely debilitating with a significant 
impact on quality of life. These symptoms can also have an impact on 
mental health, creating the additional burden of anxiety and distress. 
 
   About ObsEva 
 
   ObsEva is a biopharmaceutical company developing and commercializing 
novel therapies to improve women's reproductive health and pregnancy. 
Through strategic in-licensing and disciplined drug development, ObsEva 
has established a late-stage clinical pipeline with development programs 
focused on treating endometriosis, uterine fibroids and preterm labor. 
ObsEva is listed on the Nasdaq Global Select Market and is trading under 
the ticker symbol "OBSV" and on the SIX Swiss Exchange where it is 
trading under the ticker symbol "OBSN". For more information, please 
visit www.ObsEva.com. 
 
   About Yselty(R) (Linzagolix) 
 
   Yselty(R) (linzagolix) is a novel, once daily, oral GnRH receptor 
antagonist with a potentially best-in-class profile. Linzagolix is 
currently in late-stage clinical development for the treatment of heavy 
menstrual bleeding associated with uterine fibroids and pain associated 
with endometriosis. ObsEva licensed linzagolix from Kissei in late 2015 
and retains worldwide commercial rights, excluding Asia, for the 
product. Linzagolix is not currently approved anywhere in the world. 
 
   About Kissei 
 
   Kissei is a Japanese pharmaceutical company with approximately 70 years 
of history, specialized in the field of urology, kidney-dialysis and 
Unmet Medical Needs. Silodosin is a Kissei product for the treatment of 
the signs and symptoms of benign prostatic hyperplasia which is sold 
worldwide through its licensees. KLH-2109/OBE2109 is a new chemical 
entity discovered by Kissei R&D. 
 
   Cautionary Note Regarding Forward-Looking Statements 
 
   Any statements contained in this press release that do not describe 
historical facts may constitute forward-looking statements as that term 
is defined in the Private Securities Litigation Reform Act of 1995. 
These statements may be identified by words such as "believe", "expect", 
"may", "plan", "potential", "will", and other similar expressions, and 
are based on ObsEva's current beliefs and expectations. These 
forward-looking statements include expectations regarding the potential 
therapeutic benefits and the clinical development of ObsEva's product 
candidates. These statements involve risks and uncertainties that could 
cause actual results to differ materially from those reflected in such 
statements. Risks and uncertainties that may cause actual results to 
differ materially include uncertainties inherent in the conduct of 
clinical trials and clinical development, including the risk that the 
results of earlier clinical trials may not be predictive of the results 
of later stage clinical trials, related interactions with regulators, 
ObsEva's reliance on third parties over which it may not always have 
full control, the impact of the novel coronavirus outbreak, and other 
risks and uncertainties that are described in the Risk Factors section 
of ObsEva's Annual Report on Form 20-F for the year ended December 31, 
2020 and other filings ObsEva makes with the SEC. These documents are 
available on the Investors page of ObsEva's website at 
http://www.ObsEva.com. Any forward-looking statements speak only as of 
the date of this press release and are based on information available to 
ObsEva as of the date of this release, and ObsEva assumes no obligation 
to, and does not intend to, update any forward-looking statements, 
whether as a result of new information, future events or otherwise. 
 
 
 
   For further information, please contact: 
 
   CEO Office contact 
 
   Shauna Dillon 
 
   [e-mail] 
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   [phone] 
 
   Investor Contact: 
 
   Joyce Allaire 
 
   [e-mail] 
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   Attachment 
 
 
   -- Press Release in Pdf 
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April 30, 2021 16:05 ET (20:05 GMT)